MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161006
Medical Device Problem Codes	Inadequate User Interface (2958); No Flow (2991); No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to hamilton medical ag, that: the hamilton-t1 ventilator (pn: 161006 / sn: (b)(6) failed to ventilate during use/whilst the staff was preparing the patient for transfer.Disconnected from wall oxygen port to attach oxygen bottle.The ventilator stopped delivering breaths.Re-attached to wall, but the ventilator did not restart.When disconnected circuit from et tube (endotracheal tube), no air was flowing through the circuit.Screen frozen and staff was unable to change any values.Patient involvement with medical intervention (changing to a different hamilton-t1 ventilator) was reported.However, no patient, user or third-party harm was reported.
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4).Investigation is ongoing.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: jan schaufelberger ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 25514960
• Report Number: 3001421318-2026-00378
• Device Sequence Number: 9993219
• Product Code: CBK
• UDI-Device Identifier: 07630002801850
• UDI-Public: 07630002801850
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 161006
• Device Catalogue Number: 161006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 06/16/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown